Duration of Clopidogrel Therapy After Drug-Eluting Stent (DES-LATE)

Seung-Jung Park5,000 enrolled

Overview

This is randomized-controlled trial to evaluate the difference of composite of cardiac death, myocardial infarction, or Stroke between the dual antiplatelet therapy group and the aspirin monotherapy group after 1-year of drug-eluting stents implantation.

This is subsequent clinical trial of previously published pooled analysis of the REAL-LATE and the ZEST-LATE Trial, in which nonsignificant higher trend for increased rate of death (all-cause and cardiac), myocardial infarction, or stroke in the dual antiplatelet therapy group compared to the aspirin monotherapy group was noted.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

5,000

Conditions

Coronary Artery Disease

Interventions

Aspirin monotherapyDRUG

stopping clopidogrel at 1 year after DES

Aspirin,ClopidogrelDRUG

continue aspirin and clopidogrel 1year after DES

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * 1\. Patients had undergone DES implantation at least 12 months before enrollment, had not had a MACE (death, MI, stroke, or repeat revascularization) or major bleeding, and were dual-therapy at the time of enrollment. * 2\. Time for index PCI to randomization: 12-18 months Exclusion Criteria: * Contraindications to the use of antiplatelet drugs (e.g., a concurrent bleeding diathesis or a history of major bleeding) * Concomitant vascular disease requiring long-term use of clopidogrel * Other established indications for clopidogrel therapy (e.g., a recent ACS). * Noncardiac coexisting conditions with a life expectancy \< 1 year.

Locations (19)

Soonchunhyang University Bucheon Hospital

Bucheon-si, South Korea

Busan Saint Mary's Hospital

Busan, South Korea